Clinical Evaluation Report Sample

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A clinical evaluation report shall be compiled to document the clinical evaluation and its output on a specified time schedule. The clinical evaluation report should contain sufficient information to be read and understood by an independent party like regulatory authority or notified body. Therefore, it should provide sufficient detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made and all conclusions reached.

The Organization must follow following step while doing documentation of clinical evaluation report ( for education and understanding purpose only).

Clinical Evaluation Report Sample

(CER Report Template)

01. Table of content

02. Summary

03. Scope of the clinical evaluation

  • General details
  • Device Description
  • Device Classification
  • Intended use
  • Contraindication
  • Indication of Use04. Clinical background, current knowledge, state of the art05. Device under evaluation
  • Type of evaluation
  • Demonstration of equivalency
  • Determination of equivalent devices
  • Analysis and evaluation of equivalent devices
  • Supporting data to claim equivalency
  • Biocompatibility testing (biological and clinical equivalence)
  • Bench testing (technical and clinical equivalence)06. Clinical data generated and held by the manufacturer
  • Post market surveillance study
  • Objective
  • Study design
  • Study outcome
  • Post market clinical follow up
  • Pre-clinical studies07. Clinical data from literature08. Summary and appraisal of clinical data09. Analysis of clinical data
  • Requirement on safety
  • Requirement on Acceptable Benefit/Risk Profile
  • Requirement on Performance
  • Requirement on acceptability of side-effects10. Conclusion11. Date of next clinical evaluation12. Date & Signatures13. Qualification of the responsible evaluators

    14. Reference

    15. Records

The contents of the clinical evaluation report are relevant to [Device Name] medical devices manufacture and marketed by [company name] which may vary according to the nature and history of the device under evaluation

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